Implant for the treatment and/or for replacement of an inflammed, thrombosed or degenerated heart valve

Abstract

The invention relates to an implant ( 1 ) for treating and/or for replacing a heart valve ( 100 ) diseased by an inflammation and/or infection, wherein the implant ( 1 ) has a catching device ( 2 ) which, in a compressed state, can be introduced in a minimally invasive manner into the body of the patient, and which can be expanded at the implantation site on the diseased heart valve ( 100 ), wherein the catching device ( 2 ) is designed, at least in the implanted and expanded state, to compartmentalise tissue changes or tissue deposits ( 101 ), in particular in the form of heart valve vegetation or deposits, in particular by using the catching device ( 2 ) to engage around and/or receive at least regions of the tissue change or deposit ( 101 ).

1 . An implant for the treatment and/or replacement of a diseased inflamed and/or infected heart valve, wherein the implant comprises a capture device which is able to be introduced into a patient's body in a compressed state in minimally invasive manner and expanded at an implantation site on the diseased heart valve, wherein the capture device, at least in an implanted and expanded state, is designed to compartmentalize tissue changes or tissue deposits in the form of heart valve vegetation or deposits by the capture device at least partially grasping and/or capturing the tissue change or deposit,
 wherein the capture device comprises an anchoring structure for the fixation and/or positioning of the capture device at the implantation site, and wherein the capture device comprises a capturing structure connectable to the heart valve which extends downstream, as viewed in the direction of the blood flow, from the anchoring structure into a vessel connected to the diseased heart valve in terms of flow and exhibits at least one clamping area in the expanded state which is designed to interact with at least one heart valve leaflet of the diseased heart valve in the expanded and implanted state of the capture device such that at least one heart valve leaflet is pressed toward a vascular wall and at least partially enclosed by the capture device.   
     
     
         2 . (canceled) 
     
     
         3 . The implant according to  claim 1 ,
 wherein the at least one clamping area comprises at least one clamping arm or clamping bracket designed to at least partly expand radially upon the expansion of the capture device in the implantation site, wherein the clamping area designed to interact at a distal end region on the far side from the anchoring structure with a further abutment structure to be implanted.   
     
     
         4 . The implant according to  claim 1 ,
 wherein the implant further comprises an expandable replacement heart valve which can be introduced into the patient's body in a compressed state in minimally invasive manner and is expandable at the implantation site on the diseased heart valve such that the replacement heart valve assumes the function of a native heart valve, wherein the replacement heart valve and the capture device are connected or connectable to one another by means of a common anchoring structure designed to be positioned and fixed in an area of roots of the heart valve leaflets of the native heart valve.   
     
     
         5 . The implant according to  claim 4 ,
 wherein the implant is designed to expand incrementally over time in the implantation site on the diseased native heart valve, wherein the capture device expands in a first step and the replacement heart valve expands in a second step; or   wherein the implant is designed to expand incrementally over time in the implantation site on the diseased native heart valve, wherein the replacement heart valve expands in a first step and the capture device expands in a second step.   
     
     
         6 . The implant according to  claim 1 ,
 wherein the implant further comprises a structure able to be implanted separately from the capture device and which exhibits a substantially annular self-expanding structure and is insertable into pockets of a native heart valve and serves as abutment for the capture device or the clamping area of the implant.   
     
     
         7 . The implant according to,  claim 1 , wherein the implant and/or an abutment structure allocated to the implant is/are designed to release antimicrobial, antithrombotic or cell growth-inhibiting active substances at least in the implanted state. 
     
     
         8 . The implant according to  claim 7 ,
 wherein for the release of the active substances, the capture device and/or a replacement heart valve that may be part of the implant and/or an abutment structure allocated to the implant has a coating of the active substances.   
     
     
         9 . The implant according to  claim 7 ,
 wherein for the release of the active substances, the implant or components of the implant and/or the abutment structure allocated to the implant comprise at least one bioresorbable structure exhibiting a fibrous, non-woven and/or membrane structure; and/or wherein the implant or components of the implant and/or the abutment structure allocated to the implant comprise at least one active substance-releasing area which is at least partially coated or covered by at least one polymer material and designed to control the direction of release of the active substance and/or at least greatly reduce a release of the active substance toward the at least one polymer material used for the coating.   
     
     
         10 . A catheter for introducing the implant of  claim 1  into a body of a patient, wherein the catheter has a catheter tip able to be manipulated via a handle of the catheter such that the implant can be released from the catheter tip incrementally. 
     
     
         11 . A system for the treatment or the replacement of an inflamed, thrombosed or degenerated heart valve comprising the implant according to  claim 1  and a catheter, wherein the catheter has a catheter tip able to be manipulated via a handle of the catheter such that the implant can be released from the catheter tip incrementally, and wherein the implant is designed to be able to be accommodated in the catheter tip when the implant is extended in the longitudinal direction and in a reduced state relative to the radial direction of the implant, and wherein the catheter tip is designed to accommodate the implant when the implant is extended in the longitudinal direction and in the reduced state relative to the radial direction of the implant. 
     
     
         12 . The system according to  claim 11 ,
 wherein the system comprises an additional and/or independent at least substantially annular, self-expanding implant which is designed to serve as an abutment for the implant of  claim 1  and which is able to be folded by radial stretching and accommodated in folded form in the catheter and implanted at the implantation site such that in the implanted state of the implant, at least some areas of at least one valve leaflet of the heart valve to be treated can be accommodated between the implant of  claim 1  and the additional and/or independent implant.   
     
     
         13 . The system according to  claim 12 ,
 wherein the additional and/or independent implant is designed to be receivable in the catheter tip in the compressed state such that the additional and/or independent implant in the compressed state is not aligned coaxially but rather orthogonally to the catheter tip axis and is also able to be incrementally released at the implantation site by means of one or more pressure-resistant connections.   
     
     
         14 . A method for the treatment or the replacement of an inflamed, thrombosed, or degenerated heart valve, wherein the method comprises the method step of compartmentalizing tissue changes or tissue deposits in the form of heart valve vegetation or deposits, and by the tissue changes or tissue deposits being at least partially captured and/or grasped by a capture device. 
     
     
         15 . The method according to  claim 14 ,
 wherein the method further comprises the method step of implanting a replacement heart valve to replace the diseased native heart valve, wherein the step of compartmentalizing and the step of implanting the replacement heart valve are preferably performed chronologically sequentially; and/or   wherein the method further comprises the method step of releasing antimicrobial, antithrombotic and cell growth-inhibiting active substances, wherein the release ensues in situ.